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Completed

NCT Number: NCT02483741

The Use of Manuka Honey to Improve Healing After Third Molars Surgery

Since there is an evidence that Manuka honey is an antibacterial agent, the present study aims to confirm this characteristic and assess its effect in improving healing and reducing postsurgical symptoms, if topically applied after the surgical removal of impacted mandibular third molars

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Key information

Age range

20 year–37 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Oral and Maxillofacial Surgery, University of Damascus Dental School

Damascus, Damscus, DM20AM18, Syria

About this study

Sufficient evidence exists recommending the use of honey in the management of acute wounds and burns. Studies revealed that the healing effect of honey could be classified by its antibacterial, antiviral, anti-inflammatory and antioxidant properties of its components. Manuka honey has been shown to inhibit a wide range of microorganisms, including multiresistant strains. This unique honey is derived from flowers of manuka tree (Leptospermum scoparium) in New Zealand. Dihydroxyacetone and methylglyoxal are unique and naturally occurring constituents of manuka honey that correlate with its antibacterial activity.

Since surgical extraction of impacted molars is one of the most common operations in the oral cavity and the postoperative symptoms disturbing the patient may reduce the quality of health service, this study aims to assess the healing potential of Manuka honey in reducing these symptoms by comparing the outcome of extraction of impacted lower molars with and without topical application of Manuka honey into the extraction socket.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Asymptomatic, Symmetrical, Bilateral Impacted Third Molars

Exclusion criteria

  • Uncontrolled diabetes,
  • Hypersensitivity to Honey
  • Alcoholism,
  • Drug abuse,
  • Pathological condition in the region

Treatment and study plan

Manuka Honey

Biological

This material is going to be placed into the sockets of the extracted third molars in the experimental group

Primary outcomes

  1. Levels of postoperative discomfort

    Time frame: 7 days after the surgical removal of third molars

    Postoperative Symptom Severity (PoSSe) Scale will be used for this variable. The patient will be asked to fill in a questionnaire on the 7th day following surgery. This questionnaire is used to assess postoperative discomfort in patients who have third molars extracted. PoSSe Scale consists of 7 sub-scales that investigate the patient's ability to enjoy food; speak properly; perceive altered sensations, appearance, pain, and sickness; and interference with daily activities.

  2. Change of facial contours due to swelling

    Time frame: Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.

    In order to assess facial swelling, the distances between the labial commissure and the tragus, and between the lateral canthus and the gonion will be measured.

    The change between 3 days and before surgery will give an idea about the amount of swelling that occurred following surgery.

    Between 3 days and 7 days will give an idea about the change that occurred in this period.

  3. Change of the masticatory muscles status

    Time frame: Measurements will be taken before surgery, on the 3rd and on the 7th days after surgery.

    Mouth opening range will be assessed by measuring the distance between the upper and lower incisors using a vernier caliper when the patient is asked to open his/her mouth as much as possible.

    The presence of limited opening of the mouth is an indication of trismus.

  4. Pain and Change of pain

    Time frame: This will be assessed on the 3rd and 7th day following surgery

    using a Visual Analog Scale of Faces (VASoF).

  5. The presence or absence of alveolar osteitis

    Time frame: This will be assessed on the 3rd and 7th day following surgery

    The presence of a dry socket condition will be checked out at two time points.

Secondary outcomes

  1. Time required to hemostasis

    Time frame: This will be recorded by the patient in the immediate postsurgical phase (i.e. between 10 minutes up to 72 hours following surgery)

  2. Bone density and quality

    Time frame: at six months following surgery

    This will be assessed using Cone-beam computed tomography (CBCT) images. Hounsfield Units will be used to quantify bone density and quality.

  3. Change of bone healing status

    Time frame: at 3 and six months following surgery

    This will be assessed using panoramic radiographs

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

The Effect of Topical Application of Manuka Honey on Healing After Extraction of Impacted Lower Third Molars: A Split-Mouth Design Randomized Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 29, 2015
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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